Status:
COMPLETED
Evaluation of the Evolution of Biological and Imaging Markers of Bone and Cartilage Degradation in Patients With Knee Osteoarthritis Receiving Intra-articular Injections of a Hyaluronan Derivative HYMOVIS®
Lead Sponsor:
Fidia Farmaceutici s.p.a.
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
This pilot study MOKHA is aimed to evaluate the beneficial effect of HYMOVIS® on cartilage of patients suffering of knee osteoarthritis as revealed by using scientifically sound, objective measurement...
Detailed Description
This study is a post-marketing, open-label, prospective and multicentric pilot study in 50 patients suffering from knee OA. Investigators will be rheumatologists or articular disease specialists from ...
Eligibility Criteria
Inclusion
- Male or female between the age of 40 and 80 with BMI ≤ 40
- Monolateral (unless contralateral knee is grade I and asymptomatic) femorotibial knee OA associated or not with femoropatellar knee OA
- Responding to clinical and radiological criteria of the American College of Rheumatology (ACR) (Appendix 1)
- Symptomatic for more than 6 months in the most painful knee
- Radiological Kellgren \& Lawrence (K\&L) II or III in radiographs from less than 12 months (Appendix 2)
- Mean knee pain score at rest over the last 24 hours evaluated on VAS (0-100) ≥ 40 (Appendix 3) with a washout period for Paracetamol and oral NSAIDs depending on the half-life of the drug (Appendix 4). The most painful knee is considered.
- Able to follow the instructions of the study
- Having signed an ICF
Exclusion
- Related to the OA pathology
- Bilateral (except asymptomatic and grade I) OA of the knee
- Radiological K\&L grade I or IV (Appendix 2)
- Chondromatosis or villonodular synovitis of the knee
- Recent trauma (\< 1 month) of the knee responsible of the symptomatic knee
- Acute inflammatory OA (KOFUS (Knee Osteoarthritis Flare Up Scale) score ≥ 7, Appendix 5)
- Articular disease resulting from articular dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, hemophilia, hemochromatosis….
- Inflammatory disease i.e. rheumatoid arthritis, gout, infectious arthritis, acute calcium pyrophosphate arthritis
- Pathologies interfering with the evaluation of OA (radiculalgia in the lower limbs, arteritis…..)
- Presence of another joint (other than the target knee) affected by OA (confirmed in radiographs and symptomatic)
- Related to treatments
- Corticosteroids injection in the target knee in the last month before first injection
- Hyaluronan injection in the target knee in the last 6 months before first injection
- Arthroscopy and surgery in the target knee in the last 6 months before first injection
- Oral corticotherapy ≥ 5mg/day (in Prednisone equivalent) in the last 3 months before first injection
- OA treatments based on curcuma extract (e.g. FLEXOFYTOL) in the last 3 months before first injection
- Change in the dosage of SYSAD i.e. chondroitin, glucosamine, diacerein or avocado-soy unsaponifiables in the last 3 months before first injection
- Paracetamol and oral NSAIDs before inclusion and follow-up visits (washout period depending on the half-life of the drug, Appendix 4).
- Osteoporosis-related treatments based on strontium ranelate, selective estrogen-receptor modulator (SERM) and parathormone (PTH) in the last 12 months before first injection
- An anticipated need for any forbidden OA treatments during the trial
- Contraindications to HYMOVIS®: hypersensitivity to the product components and infections or skin diseases in the area of the injection site.
- Non-pharmacologic therapy (including physical therapy) for the lower extremities initiated in the month before first injection
- Anticoagulant (coumarinic compound) and heparin
- Related to associated diseases
- Severe diseases (liver or renal failure, lung/heart disease, tumor, HIV….)
- Allergy or contra-indication to hyaluronan
- Severe alteration of mobility enabling functional evaluation
- High risk of hemorrhage and risk of infection at the site of injection
- Anticipated need for any surgical or other invasive procedure during the trial including prosthesis in the target knee
- Related to patients
- Participation to a therapeutic clinical trial in the last 3 months before first injection
- Under guardianship or judicial protection
- Pregnancy, breastfeeding, planned conception, premenopausal women without contraception, tubal ligation or hysterectomy
- Related to MRI counter-indication
- Patient with a pacemaker, an implantable defibrillator, neurosurgical clips, a neurostimulator, cochlear implant, a stent from less than 3 weeks, an insulin pump
- Patient with a ferromagnetic splinter in the body, or having wire sutures
- Serious mobility problem (Parkinson, tremors),
- Claustrophobia
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 6 2017
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04293861
Start Date
April 1 2015
End Date
June 6 2017
Last Update
March 6 2020
Active Locations (8)
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1
Service de Rhumatologie CHU Dinant-Godinne (Site Godinne)
Yvoir, Namur, Belgium, 5530
2
Service de Rhumatologie, CHU Brugmann
Brussels, Belgium, 1020
3
CHR Citadelle de Liège
Liège, Belgium, 4000
4
Service de Rhumatologie CHU Liège
Liège, Belgium, 4000